[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460407":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital Muenster","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Implementation of the KDIGO bundle for at least 72 hours 1. Discontinuation of all nephrotoxic drugs when possible 2. Optimization of volume status and perfusion pressure. 3. Consideration of a functional hemodynamic monitoring. 4.Close monitoring of serum creatinine, and urinary output 5. Avoidance of hyperglycemia 6. Considerations of alternatives to radiocontrast agents 7. Non-invasive or invasive diagnostic workup 8. Nephrology consultation.",[13],"Procedure: Implementation of the KDIGO bundle)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Patients in the control group will receive standard of care. According to best clinical practice, this includes the following targets (unless specific individual targets are chosen by treating physician):\n\n* mean arterial pressure (MAP): ≥ 65 mmHg\n* passive leg raising test (PLRT): increase of cardiac output (CO)\\\u003C10%",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Implementation of the KDIGO bundle)","Comprehensive Implementation of the Bundle recommended by the \"Kidney Disease: Improving Global Outcomes Group \"(KDIGO bundle)",[9],[26],{"name":27,"affiliation":28,"role":29},"Zarbock, MD","University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine","STUDY_CHAIR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+49-251-8347252","aki@anit.uni-muenster.de",{"name":36,"role":32,"phone":18,"phoneExt":18,"email":34},"Meersch, MD",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":18},"University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine","RECRUITING","Münster","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],7.62571,51.96236,{"lat":48,"lon":47},{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53],{"name":54,"class":55},"Baxter Healthcare Corporation","INDUSTRY","100460407","effect-of-an-intervention-to-prevent-acute-kidney-injury-versus-standard-care-in-high-risk-patients-after-major-surgery-100460407",false,"NCT05275218","Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery","Effect of an Extended \"Kidney Disease: Improving Global Outcomes\" (KDIGO) Bundle Versus Standard of Care Therapy on Persistent Acute Kidney Injury in High-risk Patients After Major Surgery","PrevProgAKI","Inclusion Criteria:\n\n1. Adult patients (age ≥18 years)\n2. Moderate or severe AKI ((defined by the 2012 KDIGO criteria, KDIGO stage 2 and 3), determined by either serum creatinine or urine output) within 72h after a surgical procedure\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Dialysis-dependent chronic kidney disease\n2. Prior kidney transplant\n3. Infections with human immunodeficiency virus or hepatitis\n4. Hepatorenal syndrome\n5. Pregnancy or breast-feeding\n6. Participation in another interventional trial that investigates a drug that affects the kidney function within the last 3 months\n7. Persons held in an institution by legal or official order\n8. Persons with any kind of dependency on the investigator or employed by the responsible institution or investigator","ALL","18 Years",{"count":67,"type":68},480,"ESTIMATED","INTERVENTIONAL",[71],"NA","There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.\n\nTo investigate whether an implementation of a supportive extended care \"bundle\" in high-risk patients for persistent acute kidney injury (AKI) can reduce the occurrence of persistent surgical AKI.\n\nIn order to investigate whether the extended KDIGO bundle can prevent persistent AKI in patients with high chemokine ligand 14 (CCL14) as well as in patients with low CCL14, patients will be randomized with stratification by the CCL-value.",[74],"Acute Kidney Injury (Nontraumatic)",[76,77,78],"surgery","biomarker","CCL14 protein","2024-07-30",{"date":81,"type":82},"2024-08-01","ACTUAL",{"date":84,"type":82},"2023-03-22",{"date":86,"type":68},"2025-12",{"name":5,"class":6},1]